Moderna eyes EUA next week
Food and Drug Administration (FDA) Director General Eric Domingo on Sunday said Moderna is set to apply for emergency use authorization (EUA) next week, a development expected to boost the country’s vaccination campaign.
“Moderna is scheduled to apply for EUA next week. It is still collating all the necessary documents before submitting its application,” Domingo said.
Moderna secured its EUA from the United States (US) FDA on 18 December 2020. It has an efficacy rate of 94.1 percent against coronavirus disease (Covid-19).
At the same time, Domingo said the FDA is still currently reviewing the EUA application of Indian-based vaccine, Bharat Biotech.
“They still need to submit additional documents that is why we have yet to approve the EUA application. Once the company completes the documents, we can finish the review,” Domingo said.
According to Domingo, the EUA application of Janssen by Johnson and Johnson is being evaluated by the vaccine experts.
“Janssen was the last to apply for an EUA and it only needs a single dose, so it is under evaluation by our experts,” he added.
On the other hand, Domingo allayed the fears of local government units (LGU) and private companies following the FDA’s order to temporary suspend the use of AstraZeneca for aged 59 and below.
“Our vaccine expert panel will come up with a recommendation this week so that if we will resume the vaccination using AstraZeneca, we have new guidelines to follow,” he said.
Domingo explained that the FDA did not order a total halt in the use of AstraZeneca.
“We will not stop the use. We just need additional guidance before we can start using the vaccine. It is really the best time to review it since we are still waiting for the arrival of AstraZeneca,” he said.
“It is more difficult that we will order a pause when the vaccination is ongoing but right now, there is no stock yet and once supply arrives in the country, we will be guided on what should be observed,” Domingo added.
Earlier, FDA stopped the use of AstraZeneca for 59 years old and below amid the reported incidents of blood clot in the United Kingdom (UK).
“Based on the guidance, the second dose should be given after eight to 12 weeks and we administered the first dose for AstraZeneca for four weeks now, so the next dose is still scheduled next month in time for the arrival of the second shipment from the COVAX facility,” Domingo said.
Domingo assured that the FDA will come up with new guidelines in the use of AstraZeneca within this week.
“So, definitely by this week, we can issue new guidance so we have lead time in preparation for the next delivery of AstraZeneca,” according to Domingo.
Many LGU and the private sector already placed orders of AstraZeneca vaccine.
“Our vaccine expert panel will meet tomorrow. The World Health Organization already submitted its recommendation and by end of the week, we will compile all of these recommendations to serve as guidelines in administering AstraZeneca,” he said.
Domingo said that the reported cases of blood clot in UK should not be ignored by the government.
“We need to address the fears of the people as they are also aware of the report from the European Medicine Agency and make sure to maximize the benefits from this vaccine,” he said.